Targretin (Bexarotene) - Summary

TARGRETIN SUMMARY

Targretin® (bexarotene) capsules, 75 mg

Targretin (bexarotene) is a member of a subclass of retinoids that selectively activate retinoid X receptors (RXRs). These retinoid receptors have biologic activity distinct from that of retinoic acid receptors (RARs). Each soft gelatin capsule for oral administration contains 75 mg of bexarotene.

Targretin (bexarotene) capsules are indicated for the treatment of cutaneous manifestations of cutaneous T-cell lymphoma in patients who are refractory to at least one prior systemic therapy.

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NEWS HIGHLIGHTS

Published Studies Related to Targretin (Bexarotene)

Phase I/II randomized bilateral half-head comparison of topical bexarotene 1% gel for alopecia areata. [2009.10]
BACKGROUND: Alopecia areata, hair loss caused by perifollicular T-cell infiltrates, is refractory to therapy. Bexarotene, a retinoid X receptor is a selective retinoid, induces T-cell apoptosis. OBJECTIVE: We sought to determine the safety, including the dose-limiting toxicities with adverse events, and efficacy, ie, response rate, of bexarotene in alopecia areata... CONCLUSION: Topical bexarotene 1% application is well tolerated and possibly effective. A randomized placebo-controlled trial should be conducted.

Randomized phase III trial comparing bexarotene (L1069-49)/cisplatin/vinorelbine with cisplatin/vinorelbine in chemotherapy-naive patients with advanced or metastatic non-small-cell lung cancer: SPIRIT I. [2008.04.10]
PURPOSE: This study evaluated whether the combination of the synthetic rexinoid bexarotene with first-line cisplatin/vinorelbine therapy provides additional survival benefit in patients with advanced non-small-cell lung cancer (NSCLC)... CONCLUSION: The addition of bexarotene to first-line chemotherapy did not increase survival in patients with advanced NSCLC. However, a subgroup (32%) of bexarotene-treated patients developing high-grade hypertriglyceridemia appeared to have better survival (12.3 months) than controls; thus triglyceride response may be a biomarker of survival benefit with bexarotene.

Phase III trial comparing carboplatin, paclitaxel, and bexarotene with carboplatin and paclitaxel in chemotherapy-naive patients with advanced or metastatic non-small-cell lung cancer: SPIRIT II. [2008.04.10]
PURPOSE: The purpose of this study was to determine whether addition of the synthetic rexinoid bexarotene (Targretin; Eisai Inc, Woodcliff Lake, NJ) to standard first-line carboplatin and paclitaxel therapy provides additional survival benefit in patients with advanced non-small-cell lung cancer (NSCLC)... CONCLUSION: Although the addition of bexarotene to chemotherapy did not improve survival in the overall study population, occurrence of high-grade hypertriglyceridemia in bexarotene-treated patients strongly correlated with increased survival, suggesting that bexarotene may benefit a segment of first-line NSCLC patients.

Phase II clinical trial of bexarotene gel 1% in psoriasis. [2007.05]
We report the results of a nonrandomized, open-label pilot trial investigating the safety, tolerability, and efficacy of bexarotene gel 1% in treating chronic mild to moderate plaque psoriasis. Twenty-four adults with mild to moderate stable plaque psoriasis involving 15% or less of their body surface were enrolled...

Phase II trial of bexarotene capsules in patients with advanced non-small-cell lung cancer after failure of two or more previous therapies. [2006.10.20]
PURPOSE: To evaluate the effect of bexarotene on survival in patients with relapsed non-small-cell lung cancer (NSCLC)... CONCLUSION: In the intent-to-treat population, bexarotene given as third or subsequent line of therapy for relapsed NSCLC did not achieve the intended median survival of 6 months. Survival may have been extended in patients who developed bexarotene-induced hypertriglyceremia and/or skin rash. It is important to confirm these observations in a randomized controlled trial.

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Clinical Trials Related to Targretin (Bexarotene)

Phase II Randomized Bilateral Comparison of Topical Targretin Gel 1% in Alopecia Areata [Completed]
The goal of this clinical research study is to find the most effective dose of Targretin® (bexarotene) Gel 1% that can be given to patients as a treatment for alopecia areata. The safety and tolerability of this drug will also be studied. Objectives: 1. Determine the safety and tolerability of Targretin® Gel 1% in the treatment of patients with alopecia areata. 2. Determine the efficacy of Targretin® Gel 1% in the treatment of patients with alopecia areata.

A Study of Paclitaxel and Carboplatin in Combination With Bexarotene Oral Capsules in Patients With Advanced Lung Cancer [Terminated]
The primary aim is to evaluate the safety (Phase I components) of administering bexarotene (Targretin®, LGD1069) oral capsules in combination with two Taxol® and carboplatin (Paraplatin®) schedules to patients with stage IIIB and IV non-small cell lung cancer. This study will also evaluate the preliminary efficacy (Phase II component) of bexarotene oral capsules in combination with the weekly Taxol® schedule and carboplatin in these patients.

Study Evaluating Two Dose Levels of Targretin Capsules in Patients With Refractory Cutaneous T-cell Lymphoma (CTCL) [Completed]
This is a multicenter, randomized, open-label, Phase IV study to assess the efficacy, tolerability and safety of two initial dose levels of bexarotene capsules in patients with refractory cutaneous T-cell lymphoma (CTCL).

Study of Tarceva and Targretin in Stage I-II Lung Cancer [Completed]
The purpose of this study is to learn the effects on lung cancer of 2 new drugs, Tarceva and Targretin, given in combination before surgical removal of the tumor. Tarceva is approved by the Food and Drug Administration (FDA) for lung cancer. Targretin is approved for the treatment of cutaneous T-cell lymphoma. This combination of drugs is experimental.

BATTLE Program: Tarceva and Targretin in Patients With NSCLC [Active, not recruiting]
The goal of this clinical research study is to evaluate the effectiveness of Tarceva® (OSI-774, erlotinib hydrochloride) in combination with Targretin® (bexarotene) in treating NSCLC. The safety of this treatment will also be studied, as well as the treatment's effect on different cells in the body and the participants' overall response.

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Reports of Suspected Targretin (Bexarotene) Side Effects

Dehydration (7),  Lung Infection (3),  Anaemia (3),  Febrile Neutropenia (3),  Haematochezia (3),  Abdominal Pain (2),  Tinnitus (2),  Coagulopathy (2),  Deafness (2),  Cardiac Failure Congestive (2), more >>